Regulatory strategy and preparation for pre-IND meeting with the FDA

Challenge: A biotech company working in the microbiome space engaged Alacrita to provide advice about regulatory strategy and to prepare for and conduct a pre-IND meeting with the FDA. The product in...
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Validating two potential hormone replacement therapy products with KOLs

Challenge: A clinical-stage company developing novel transdermal patch technology asked us to validate two potential hormone replacement therapy products with KOLs. The main focus was to evaluate the...
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Oligo technology applications mapping

Challenge: A startup with a novel technology for enzymatic synthesis of dsDNA approached Alacrita to assess potential opportunities for the technology in the biopharma space. Hitherto the company had...
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LNP technology and competitive landscape

Challenge: A privately held biotech company using AI/machine learning/Big Data to develop novel LNPs and LNP formulations for particular payloads instead of using a traditional “trial and error”...
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Biologics manufacturing support for a discovery stage microbiome company

Challenge: For a discovery stage microbiome company, Alacrita supplied a senior biologics manufacturing specialist to act as Interim VP CMC.
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Pre-IND meeting support for repurposed drug for stroke

Challenge: Our client was working with a family office which had invested in a novel IV formulation of a repurposed asset for the treatment of ischemic stroke. With a promising completed phase II...
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CMC and regulatory affairs gene therapy support

Challenge: A biotech company developing novel gene therapy approaches for in vivo cell trans-differentiation had lead programs in IND-enabling studies for two indications. The client requested...
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Regulatory assessment of a generic anti-diabetic peptide drug

Challenge: An established Alacrita client had developed a generic version of a major anti-diabetic peptide drug. It requested a report, based from a number of key questions posed by the client, on...
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Virtual Stewardship of a Targeted Cancer Therapy to an IND Submission

An early-stage biotech company developing a targeted cancer therapy engaged Alacrita to provide expertise to help them navigate an upcoming IND submission. An Alacrita partner and medical oncologist...
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University life sciences IP and project portfolio review

Challenge: Alacrita developed techno-commercial development plans for selected top priority projects. The client, King's Commercialisation Institute, convened an expert panel which then selected...
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Medical oversight support for oncology clinical trials

Challenge:  A listed biotech company conducting Phase III clinical trials in an oncology indication needed Chief Medical Officer support for multiple clinical activities in Europe and the United...
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Development & Refinement of a Patient-Reported Outcome (PRO) Strategy

Challenge: Alacrita was approached by a company developing an enzyme approved by the FDA for the treatment of toxic plasma chemotherapy concentrations in patients with delayed clearance due to...
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